The present disclosure is directed to an ostomy device. More particularly, the present disclosure pertains to an adaptive flange for an ostomy appliance that is movable between a fixed position and a floating position.
An ostomy appliance or system is a medical device or prosthetic that provides a means for the collection of waste from a stoma, typically created as a result of a surgical procedure to divert a portion of the colon or small intestine. One type of ostomy appliance device is a pouch that is attached to the user's peristomal area, around the formed stoma.
There are two principal types of pouching systems, one-piece systems and two-piece system. In a one-piece system, a faceplate assembly which includes barrier element is adhered to the user's skin, surrounding the stoma. The barrier is a hydroscopic seal element that provides a waste/liquid/gas seal between the user's skin and the pouch. The pouch is directly adhered to an opposite side of the faceplate assembly or barrier. One-piece designs require that the user remove the entire appliance, including the faceplate or barrier, from the peristomal area to empty or flush the pouch or to replace the pouch.
Two-piece systems likewise include a barrier or a faceplate to adhere to the user's peristomal area. However, unlike one-piece systems, two-piece systems include one of a pair of coupling rings or flanges fixedly attached to the opposite side of the barrier. The collection pouch includes a coupling ring to mate with the barrier ring. The coupled rings or flanges attached mechanically to provide a seal. The two-piece design allows the user to remove the pouch, without removing the barrier that is adhered to the skin, to permit emptying, cleaning, venting or the like. The pouch can then be reapplied or a new pouch applied to the existing barrier or faceplate. The can help to reduce the discomfort and irritation associated with removing adhesive or gel from the skin.
One of the difficulties in use of the two-piece design is that is may be difficult to separate and join the pouch and barrier rings to one another. Since the barrier ring is so close to the user's body (peristomal area), it is necessary to urge one's fingers between the ring and the faceplate or barrier to grasp the barrier ring so that the pouch (and pouch ring) can be pulled to effect separation. This can be difficult for even those users with full dexterity and becomes more difficult for those that have less than full dexterity of those that are overweight.
To address this concern, two-piece designs have been developed that include a floating flange. In such an arrangement, the barrier ring or flange is mounted to the faceplate or barrier by a flexible membrane, such as a short, polymeric element that is scaled to both the faceplate or barrier and to the ring. The membrane serves as an extension piece between the faceplate/barrier and the barrier ring. This allows the barrier ring to be accessed slightly farther away from the barrier and the user's skin. It has been found that this configuration greatly increases the ability of those with both full dexterity, as well as those with limited dexterity or access to the peristomal area to grasp the barrier ring when removing the pouch.
While the two piece design functions well for its intended purpose, there are some drawbacks. For example, the increased distance between the user and the pouch (or the barrier and the pouch) and the flexible membrane can induce less of a secure feeling to the user. Also, with a floating flange, the pouch can tend to pull away from the user and therefore be more likely to be visible (e.g., create a noticeable bulge beneath the user's clothing), especially when the pouch contains a significant amount of stomal output. This can result in the user becoming less likely to maintain normal or active everyday activities.
Accordingly, there is a need for a flange that combines the low profile, security and other advantages of the fixed flange arrangement with the comfort, flexibility, and ease of use of the floating flange arrangement.